Flourish Vaginal Care system for Neovaginal Microbiome
Phase-Based Progress Estimates
Effectiveness
Safety
Papillon Wellness Center, New Hope, PA
Neovaginal Microbiome
Flourish Vaginal Care system - DeviceEligibility
18+
All Sexes
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Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This trial looks at whether a vaginal wellness system can help establish a microbiome in transgender women. The Flourish Vaginal Care system is being used in a trial to treat Neovaginal Microbiome, and there is no placebo group. The system has previously been approved by the FDA for a different condition.
Treatment Effectiveness
Effectiveness Progress
Other trials for Neovaginal Microbiome
Study Objectives
2 Primary · 1 Secondary · Reporting Duration: Collections at time 0, 6 weeks, and 6 months
Month 6
VSQ
Vaginal microbiome
Vaginal pH
Trial Safety
Safety Progress
Other trials for Neovaginal Microbiome
Trial Design
2 Treatment Groups
Group 2: Transgender women not using Flourish
1 of 2
Group 1: Transgender women using Flourish
1 of 2
Active Control
Experimental Treatment
60 Total Participants · 2 Treatment Groups
Primary Treatment: Flourish Vaginal Care system · No Placebo Group · N/A
Group 1: Transgender women using Flourish
Device
Experimental Group · 1 Intervention: Flourish Vaginal Care system · Intervention Types: DeviceGroup 2: Transgender women not using FlourishNoIntervention Group · 1 Intervention: Group 2: Transgender women not using Flourish · Intervention Types:
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: collections at time 0, 6 weeks, and 6 months
Closest Location: Papillon Wellness Center · New Hope, PA
N/AFirst Recorded Clinical Trial
1 TrialsResearching Neovaginal Microbiome
0 CompletedClinical Trials
Who is running the clinical trial?
Sexual Health and Wellness InstituteLead Sponsor
5 Previous Clinical Trials
158 Total Patients Enrolled
Papillon CenterUNKNOWN
Christine McGinn, DOPrincipal InvestigatorPapillon Center
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Conditions
Cancer Related
Treatments